Toronto Star (11.07.12)
Canadian researchers have announced that initial results from human clinical trials of an HIV vaccine showed no adverse effects. The vaccine, which was developed by researchers at the University of Western Ontario, is the first preventative vaccine using a genetically modified killed whole virus. The vaccine - called SAV001-H - was approved by the US Food and Drug Administration in 2011 to begin human clinical trials and is the only HIV vaccine currently being developed in Canada.
The vaccine uses HIV-1 virus that has been genetically altered so that it will not cause disease. Dr. Chil-Yong Kang, professor of virology at the university’s Schulich School of Medicine and Dentistry, and colleagues further inactivated the virus using chemicals and radiation. This strategy was used before to create successful vaccines for influenza, polio, rabies, and hepatitis A, so the researchers believed it should work.
To test the safety and tolerability of the virus, 24 healthy men and women with HIV were randomly divided into two treatment groups, one receiving the vaccine and one receiving a placebo. The participants, aged 18 to 50 years, were given monthly checkups and so far have shown no local reactions or symptoms. The main complaint was a sore arm which lasted about a day. After receiving the vaccine, the experimental group showed increased levels of HIV-1 antibodies which means that the vaccine was working to stimulate immune responses.
The second phase of clinical trials will begin in 2013, when the researchers will test the vaccine on about 600 HIV-negative volunteers at high risk for HIV infection. This test will be conducted by the CIHR Canadian HIV Trials Network. Phase 3 will enroll about 6,000 HIV-negative volunteers at high risk for the disease. The first test was carried out in the United States on persons selected at two Los Angeles hospitals. The second and third phases will be conducted in Canada, the United States, and various European countries.